Principal Medical Writer - REMOTE

Lifelancer


Date: 2 weeks ago
City: Remote
Contract type: Full time
Remote
What Youll Be Doing

  • Lead a group of writers assigned to a project, manage the greater project, and assign tasks to project team writers
  • Act as lead writer; contributes to clinical and regulatory document creation, review the work of projects writers
  • Act as principal liaison to project stakeholders
  • Work with regulatory strategist(s) and other stakeholders to create submission strategies, timelines, for regulatory submissions (e.g. meeting packages, Investigational New Drug [INDs] applications, and sections of marketing applications [NDA/BLA/MAA])
  • Creates clinical and regulatory documents according to ICH guidance
  • Ensure timeline adherence of project writers and self, provide project status updates on a regular basis to stakeholders, leads and managers


What Were Searching For

  • Bachelors degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
  • 10+ years of medical writing experience in a pharmaceutical company or a contract research organization
  • Maintains current knowledge of ICH and local regulatory authority drug research and development regulations
  • Experience mentoring and training staff
  • Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and relevant regulatory writing style.


Please apply on the Lifelancer platform at the below link for screening steps & quicker response.

https://lifelancer.com/jobs/view/31e5bbb03553a48f9fa98744eed6b167

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Graduate Visual UI Designer

Canonical, Remote
21 hours ago
The role of a Visual UI Designer at CanonicalWith Ubuntu, Canonical created the first Linux for human beings. Our design team is on a mission to turn complex, open-source software into intuitive products that can change the face of enterprise IT. We are looking for a exceptional Visual UI Designers, who share our passion.Our mission is to make enterprise-grade open...

Engineering Manager - Ubuntu Systems Management

Canonical, Remote
1 day ago
This is an engineering management role to lead the reboot of our Landscape systems management solution for Ubuntu.Ubuntu is growing rapidly in the enterprise, with estates expanding from cloud, to bare metal servers, to vSphere clusters, and of course desktops and devices. Ubuntu is easy to deploy and configure, one node at a time, but it's difficult to know where...

Cloud Professional Services Manager (EMEA)

Canonical, Remote
1 day ago
This is an opportunity to run a Professional Services team (also known as Field Engineering) team, helping customers understand and implement Canonical's open source solutions in public clouds and in their own data centers. We work across the entire spectrum of cloud offerings, from Ubuntu itself to virtualisation and private cloud, Kubernetes, and the implementation of sophisticated open source solutions...